Heart FailureNCT05324566
Evaluation of ECG Transmission and AI Models Using Apple Watch ECGs and Symptoms Data Collected Using a Mayo iPhone App
An observational study of Heart Failure and Arrhythmias, Cardiac, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of the study is to determine if the Electrocardiograms (ECGs) and symptoms data obtained from an Apple Watch and transmitted to Mayo Clinic are of sufficient quality to guide a person's care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Arrhythmias, Cardiac, Health Care Utilization
- How many people
- 4,163 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2021to 9 Jul 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients in the general public who own ECG-capable Apple Watches
Who may be able to join
- Using the Mayo patient iPhone app. (determined automatically via Mayo software).
Who cannot join
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EvALuation of ECG Transmission and AI moDels Using Apple Watch ECGs and Symptoms Data Collected usiNg a Mayo iPhone App
The purpose of the study is to determine if the Electrocardiograms (ECGs) and symptoms data obtained from an Apple Watch and transmitted to Mayo Clinic are of sufficient quality to guide a person's care.
Read the detailed description
- Patients who have the Mayo Clinic patient app and iOS 14 or higher who are 18 years of age or older will be invited to enroll.
- Patient will undergo email survey to assess ownership of Apple Watch v4 or later, and subsequent willingness to participate in the study. Those who agree will undergo digital consent and enrollment.
- A customized Mayo Clinic Study App will be available to download to their iOS device and will be used to test whether it is feasible to access ECGs and symptoms data patients have collected using their personal Apple watch that are saved on the patient's phone. The study app will facilitate transmission of past and future patient-recorded watch ECGs.
- The patient ECGs and self-reported symptoms data will be uploaded to the AI Dashboard in the patient's medical record (ECG rhythm classification facilitated by Apple ECG program).
- We will perform a retrospective review of electronic medical record data from enrolled subjects to assess the quality of the Apple Watch obtained ECGs, assess the results from the AI-ECG dashboard using obtained watch ECGs, and compare these results to prior or subsequently obtained 12 lead ECGs.
- Data analysis will be performed with steps to ensure patient confidentiality. Data will be transmitted using similar protocols as with current app data, and all data will be saved in the secure Mayo Clinic electronic environment (called the UDP).
- All patients' watch data will be compared to AI dashboard data. Additionally, clinical data in the EMR (such as blood tests, echocardiograms, and other data recorded for routine medical care) will be used to assess the utility of the watch ECG quality for AI algorithms (such as determining whether a weak heart pump is present, for example).
- Conditions
- Heart Failure, Arrhythmias, Cardiac, Health Care Utilization
- Keywords
- digital health, artificial intellegence, neural network, electrocardiogram, wearable device
- Medical subject headings
- Heart Failure, Arrhythmias, Cardiac, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ECG-capable Apple Watch | Patients who own an Apple Watch series 4 or later willing to record and upload personal ECGs to our study App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient-triggered Apple Watch ECGs recorded
Total number of patient-triggered Apple Watch ECGs recorded and uploaded by individual patients over the study period.
Measured: 12 months
Frequency of medical providers accessing Apple Watch data
Number of times a medical provider accesses the Apple Watch data via electronic medical record-linked ECG dashboard.
Measured: 12 months
Number of Apple Watch ECGs of acceptable quality
A sample of Apple Watch ECGs will undergo manual review by ECG technicians and rated using a standard data form for signal quality and diagnostic utility, summarized as the percent of "acceptable" ECGs.
Measured: 12 months
Performance of Artificial Intelligence ECG algorithms for disease prediction with Apple Watch ECGs
Artificial Intelligence ECG algorithms to predict various cardiac pathologies will be applied to Apple Watch ECGs. Accuracy and performance of AI algorithm models will be assessed by comparing AI predicted disease and patient's given medical diagnosis in the electronic medical record.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start5 May 2021
- Primary completion9 Jul 2024
- Study completion9 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,163 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul A. Friedman, Mayo Clinic
- Investigators
- Paul Friedman, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324566
- Sponsor's protocol ID
- 21-001964
- Status last verified
- Sep 2024
- First submitted
- 22 Mar 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to patient confidentiality and IRB rules, we will not make individual patient data available
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EvALuation of ECG Transmission and AI moDels Using Apple Watch ECGs and Symptoms Data Collected usiNg a Mayo iPhone App
- ClinicalTrials.gov ID
- NCT05324566
- Acronym / sponsor ID
- 21-001964
- Conditions
- Heart Failure, Arrhythmias, Cardiac, Health Care Utilization
- Keywords
- digital health, artificial intellegence, neural network, electrocardiogram, wearable device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,163 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 5 May 2021 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine if the Electrocardiograms (ECGs) and symptoms data obtained from an Apple Watch and transmitted to Mayo Clinic are of sufficient quality to guide a person's care.
Detailed description
- Patients who have the Mayo Clinic patient app and iOS 14 or higher who are 18 years of age or older will be invited to enroll.
- Patient will undergo email survey to assess ownership of Apple Watch v4 or later, and subsequent willingness to participate in the study. Those who agree will undergo digital consent and enrollment.
- A customized Mayo Clinic Study App will be available to download to their iOS device and will be used to test whether it is feasible to access ECGs and symptoms data patients have collected using their personal Apple watch that are saved on the patient's phone. The study app will facilitate transmission of past and future patient-recorded watch ECGs.
- The patient ECGs and self-reported symptoms data will be uploaded to the AI Dashboard in the patient's medical record (ECG rhythm classification facilitated by Apple ECG program).
- We will perform a retrospective review of electronic medical record data from enrolled subjects to assess the quality of the Apple Watch obtained ECGs, assess the results from the AI-ECG dashboard using obtained watch ECGs, and compare these results to prior or subsequently obtained 12 lead ECGs.
- Data analysis will be performed with steps to ensure patient confidentiality. Data will be transmitted using similar protocols as with current app data, and all data will be saved in the secure Mayo Clinic electronic environment (called the UDP).
- All patients' watch data will be compared to AI dashboard data. Additionally, clinical data in the EMR (such as blood tests, echocardiograms, and other data recorded for routine medical care) will be used to assess the utility of the watch ECG quality for AI algorithms (such as determining whether a weak heart pump is present, for example).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ECG-capable Apple Watch | – | –Patients who own an Apple Watch series 4 or later willing to record and upload personal ECGs to our study App |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the general public who own ECG-capable Apple Watches
Key inclusion criteria (1 listed)
- Using the Mayo patient iPhone app. (determined automatically via Mayo software).
Key exclusion criteria (1 listed)
- Inability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patient-triggered Apple Watch ECGs recorded
Time frame: 12 months
Total number of patient-triggered Apple Watch ECGs recorded and uploaded by individual patients over the study period.
Frequency of medical providers accessing Apple Watch data
Time frame: 12 months
Number of times a medical provider accesses the Apple Watch data via electronic medical record-linked ECG dashboard.
Number of Apple Watch ECGs of acceptable quality
Time frame: 12 months
A sample of Apple Watch ECGs will undergo manual review by ECG technicians and rated using a standard data form for signal quality and diagnostic utility, summarized as the percent of "acceptable" ECGs.
Performance of Artificial Intelligence ECG algorithms for disease prediction with Apple Watch ECGs
Time frame: 12 months
Artificial Intelligence ECG algorithms to predict various cardiac pathologies will be applied to Apple Watch ECGs. Accuracy and performance of AI algorithm models will be assessed by comparing AI predicted disease and patient's given medical diagnosis in the electronic medical record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. Due to patient confidentiality and IRB rules, we will not make individual patient data available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Friedman, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Arrhythmias, Cardiac, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient-triggered Apple Watch ECGs recorded (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.